Breast Cancer Clinical Trial
Official title:
Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not
yet known whether acupuncture is more effective than a placebo in treating hot flashes in
women with breast cancer
PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works
compared to a placebo in treating hot flashes in women with breast cancer.
OBJECTIVES:
Primary
- Determine whether acupuncture, compared to placebo, reduces the incidence of hot
flashes in women with breast cancer.
Secondary
- Determine the long-term effects of acupuncture on hot flashes.
OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified
according to concurrent treatment with selective estrogen receptor modulators,
gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use
of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no),
baseline hot flash frequency (> 7 per day), and menopausal status at diagnosis
(premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks.
- Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks.
Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks.
Patients in both arms complete a "hot flash" diary for 1 week before treatment and then
periodically during and after treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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